Insertion tools for medical devices and methods for using

ABSTRACT

The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body. In embodiments the insertion tools have an elongate hollow body ( 50 ) that is able to protect a portion of a medical device, such as a balloon of a balloon catheter, during an insertion procedure. In one embodiment the insertion tool has an elongate hollow body ( 131 ), a tapered distal end ( 135 ), and a locking mechanism ( 133 ) at the proximal end which can secure a portion of a balloon catheter. An opening at the distal end can allow passage of the balloon in a folded uninflated state.

PRIORITY

The present non-provisional application claims the benefit of commonlyowned provisional Application having Ser. No. 62/103,422, filed on Jan.14, 2015, and provisional Application having Ser. No. 62/108,256, filedon Jan. 27, 2015, both entitled INSERTION TOOL FOR MEDICAL DEVICE ANDMETHODS FOR USING, which Applications are incorporated herein byreference in their entireties.

FIELD

The disclosure relates to insertion tools that facilitate the insertionof a medical device into the vasculature of the body.

SUMMARY

Described herein are insertion tools and insertion articles for medicaldevices that are introduced into the vasculature. The insertion toolscan be used for packaging and protecting an implantable or insertablemedical device during storage and deployment. The insertion tools can beused to protect and facilitate the insertion of medical devices such asballoon catheters, stents, filters, shunts and the like. The insertiontool may facilitate guidewire insertion into a catheter lumen, protectthe surface of a balloon member of a balloon catheter or stent duringguide wire loading, provide the insertable or implantable medical devicein a desired configuration prior to insertion, protect the device fromcontamination, and/or facilitate insertion into an access device.

The insertion tool can be a part of a kit or system used for a medicalprocedure, which are also embodiments of the invention. For example, thekit can include one or more of the following components: one or moredelivery catheters, a balloon treatment device, an inflation catheter, astent, a guidewire, or combinations thereof.

Insertion tools of the present disclosure can also be used to protecthealth care professionals from having contact with drug coatings onmedical devices that are inserted into the human body. Furthermore,insertion tools can also act to protect humidity sensitive drug coatingsand to avoid accidental contact with fluids with the drug coatings priorto insertion into the body of a mammal. In some situations insertiontools can also be used to aid in the placement and insertion of valvesin transcatheter aortic valve replacement (TAVR) procedures.

In one embodiment, the invention provides an insertion tool forfacilitating the entry of a medical device such as a balloon catheterinto the body. The insertion tool includes a tubular member having awall, and proximal and distal ends, and a length between the endsdefining a first axis. In the wall of the tubular member are first andsecond separation margins, the margins being parallel to the first axis,opposite one another on the tubular member, and between the proximal anddistal ends. The separation margins are in the form of a continuousgroove or in the form of a plurality of openings in the wall of thetubular member. These separation margins can define first and secondhalves of the body member. Material of the tubular member is configuredto fracture along the length of the margins when outward forces areapplied to each half the tubular member. Also, at the proximal end ofthe tubular member is a first notch that is adjacent to the proximal endof the first separation margin and a second notch that is adjacent tothe proximal end of the second separation margin. The notches providestarting points for the separation of the tubular member. Further, thetool includes first and second separation assist members connected tothe proximal end of the tubular member and opposite one another on thetubular member, and between the first and second notches. The separationassist members can be in the form of tabs which can be pinched withfingers and then manually pulled apart. Also, the tool has a tapereddistal end wherein a thickness of the wall of the tubular member isreduced in a proximal to distal direction.

In another embodiment, the invention provides an insertion tool forfacilitating the entry of a medical device, such as a balloon catheter,into the body, the tool including a tubular member comprising a wallhaving an inner surface, an outer surface, proximal and distal ends, anda length between the ends defining a first axis. The inner surface, theouter surface, or both, of the wall comprises a plurality of ridgesrunning parallel to the first axis and about the circumference of theinner wall. The ridges define areas of the wall having a firstthickness, and between the ridges areas of the wall having a secondthickness wherein the first thickness is greater than the secondthickness. Material of the tubular member is configured to fracturealong the length of the wall between the ridges when outward forces areapplied to each half the tubular member. Also at the proximal end of thetubular member is a first notch that is adjacent to the proximal end ofa first area of the of the tubular member that is between a first set oftwo ridges, and a second notch that is adjacent to the proximal end of asecond area of the of the tubular member that is between a second set oftwo ridges. The tool also includes first and second separation assistmembers connected to the proximal end of the tubular member and oppositeone another on the tubular member and between the first and secondnotches.

Embodiments of the invention also provide methods for delivering amedical device into a patient's body using the insertion toolembodiments of the invention. The method includes steps of (a) providingan insertion tool loaded with an implantable or insertable medicaldevice such as a balloon catheter, and (b) moving, directly orindirectly, the insertable or implantable medical device from theinsertion tool into the patient's body.

In another embodiment, the invention provides another insertion tool forfacilitating the entry of a balloon catheter into the body. The toolincludes a tubular member comprising outer and inner surfaces; a distalend comprising an opening and defining inner and outer diameters,wherein inner diameter is sized to allow passage of a balloon portion ofa balloon catheter through the tubular member, a proximal end comprisingan opening and having inner and outer surfaces defining inner and outerdiameters, wherein between the proximal and distal ends the outersurface of the tubular member is sized to fit within a portion of ahemostatic valve; a length between the proximal and distal ends that isgreater that a length between two openings of a hemostatic valve; aflange arranged about the outer diameter of the proximal end; whereinthe inner diameter of the distal end is smaller than the inner diameterof the proximal end, thereby providing a tapered configuration to thetubular member.

In another embodiment, the invention also provides another method forintroducing a balloon catheter into the body. The method comprises useof a hemostatic valve and a balloon catheter insertion tool. In themethod a hemostatic valve comprising proximal and distal openings isengaged with an artery. An insertion tool is provided, the toolcomprising a tubular member comprising outer and inner surfaces; adistal end comprising an opening and defining inner and outer diameters,a proximal end comprising an opening and having inner and outer surfacesdefining inner and outer diameters, wherein between the proximal anddistal ends the outer surface of the tubular member is sized to fitwithin a portion of the hemostatic valve; a length between the proximaland distal ends that is greater that a length between two openings of ahemostatic valve; a flange arranged about the outer diameter of theproximal end; wherein the inner diameter of the distal end is smallerthan the inner diameter of the proximal end, thereby providing a taperedconfiguration to the tubular member. The distal end of the insertiontool is moved through the first and second openings of the hemostaticvalve so the proximal opening of the hemostatic valve is tightenedaround the outer surface of the insertion tool. A balloon portion of aballoon catheter is moved through the insertion tool and into theartery.

In another embodiment, the invention provides another insertion tool forfacilitating the entry of a balloon catheter into the body. The toolcomprises first and second elongate members each comprising a distalportion with a distal end, the distal portion comprising an arcuateshape that provides the distal portion with a trough-like configuration;and a proximal portion comprising a tab that is at an angle to thedistal portion. The first and second elongate members are connected toeach other by a set of hinges that bias the distal ends towards eachother, and wherein the ends can be moved apart by applying pressure tothe tabs, wherein the first and second elongate members form an openingfrom that allows passage of a balloon catheter through the tool from theproximal to distal portions when the distal ends are moved apart fromone another.

In another embodiment, the invention provides another method forintroducing a balloon catheter into the body, the method comprising useof a hemostatic valve and a balloon catheter insertion tool. The methodcomprises steps of: providing a hemostatic valve comprising proximal anddistal openings engaged with an artery; providing an insertion tool thetool comprising: first and second elongate members each comprising adistal portion with a distal end, the distal portion comprising anarcuate shape that provides the distal portion with a trough-likeconfiguration; and a proximal portion comprising a tab that is at anangle to the distal portion; wherein the first and second elongatemembers are connected to each other by a set of hinges that biases thedistal ends towards each other and wherein the ends can be moved apartby applying pressure to the tabs, wherein the first and second elongatemembers form an opening from that allows passage of a balloon catheterthrough the tool from the proximal and distal portions when the distalends are moved apart; placing the distal ends of the first and secondelongate members of the insertion tool in an opening of a hemostaticvalve; applying pressure to the tabs to move the distal ends apart fromone another to expand the opening of the hemostatic valve; and moving aballoon portion of a balloon catheter through the opening between thefirst and second elongate members of the insertion tool, through thehemostatic valve, and into the artery.

In an embodiment, the invention provides another insertion tool forfacilitating the entry of a balloon catheter into the body. The toolincludes an elongate hollow body comprising proximal and distal ends.The body is tapered at its distal end and includes an opening sized toaccommodate and allow the passage of a balloon portion of a ballooncatheter when the balloon portion is in a folded uninflated state. Thetool includes a locking mechanism located on the proximal end of theelongate hollow body capable of securing in place a portion of theballoon catheter that is proximal to the balloon portion, to restrictmovement of the balloon catheter in a proximal to distal direction.

Accordingly, the tool can be used in a method for introducing a ballooncatheter into a patient's body. The method includes a step of providingthe insertion tool with proximal and distal ends, tapered distal endwith opening, and proximal locking mechanism, where a balloon catheterdisposed and secured within the insertion tool. A balloon catheter isdisposed within the elongate hollow body, with a distal tip of theballoon catheter extending distally beyond the distal end of theelongate hollow body. The balloon catheter has a balloon portion in afolded uninflated state disposed within the elongate hollow body. Aportion of the balloon catheter that is proximal to the balloon portionis secured in place by the locking mechanism to restrict movement of theballoon catheter in a proximal to distal direction relative to theelongate hollow body. The elongate hollow body with secured ballooncatheter is moved distally so the distal tip of the balloon catheter andthe tapered distal end of the elongate body pass through an entry pointin the patient's body. The locking mechanism is then unlocked to allowmovement of the balloon catheter relative to the elongate hollow body.The balloon catheter is moved relative to the elongate hollow body.

In an embodiment, the invention provides another insertion tool forfacilitating the entry of a balloon catheter into the body. In thisembodiment, the insertion tool includes first and second elongate hollowbodies that have proximal and distal ends. The first hollow body has aproximal end with an outer diameter that is slidably movable within aninner diameter of a distal end of the second elongate member. The firsthollow body also includes an opening sized to accommodate and allow thepassage of a balloon portion of a balloon catheter when the balloonportion is in a folded uninflated state.

Accordingly, the tool can be used in a method for introducing a ballooncatheter into a patient's body. The method includes a step of providingthe insertion tool with first and second elongate hollow bodiescomprising proximal and distal ends, the first hollow body having aproximal end with an outer diameter that is slidably movable within aninner diameter of a distal end of the second elongate member, wherein aballoon catheter is disposed within the first elongate hollow body. Thedistal end of the first elongate hollow body is introduced in thepatient's body. The balloon catheter is moved distally out of the firstelongate hollow body into the patient. The first elongate hollow body ismoved proximally out of the patient's body. In one or more steps of themethod, the first elongate hollow body is moved in relation to thesecond elongate hollow body.

In an embodiment, the invention provides another insertion tool forfacilitating the entry of a balloon catheter into the body. In thisembodiment the tool includes an elongate hollow body comprising atapered distal end comprising an opening and two or more perforations,wherein the tapered end can be split open along the perforations toincrease the size of the opening and allow for passage of a ballooncatheter.

Accordingly, the tool can be used in a method for introducing a ballooncatheter into a patient's body. The method includes steps of providingthe insertion tool with its elongate hollow body and tapered distal endwith opening and two or more perforations. The tapered distal end of theelongate hollow body is introduced in the patient's body. The taperedend is forced to be split open along the perforations to increase thesize of the opening and allow for passage of a balloon catheter. Theballoon catheter is moved distally out of the opening at the splitdistal end.

In an embodiment, the invention provides an insertion article forfacilitating the entry of a balloon catheter into the body. The articleincludes a liquid or gel-filled tubular article that has an outersurface and an inner surface that are continuous with each other andthat form a cavity. The article also has a proximal and a distal endhaving opening for the cavity. The article is formed from a pliablematerial that encompasses the liquid or gel, wherein the outer and innersurfaces are able to be moved in opposite directions while the articleis stationary. The article is configured to load a balloon portion of aballoon catheter in the cavity and deliver it to an insertion site fromthe distal end.

Accordingly, the article can be used in a method for introducing aballoon catheter into a patient's body. The method includes providingthe article loaded with a balloon catheter, introducing the distal endin a patient's body, and moving the pliable material of the outer andinner surfaces to cause the movement of the balloon catheter out of thedistal end.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1a is an illustration of an insertion tool according to oneembodiment of the disclosure.

FIG. 1b is an illustration of an end of an insertion tool according toone embodiment of the disclosure.

FIG. 1c is an illustration one half of the wall of an insertion toolaccording to one embodiment of the disclosure as shown from an end ofthe tool.

FIG. 1d is an illustration of the proximal end of an insertion toolaccording to one embodiment of the disclosure.

FIG. 1e is an illustration of the proximal end of an insertion toolaccording to one embodiment of the disclosure.

FIG. 1f is an illustration of the distal end of an insertion toolaccording to one embodiment of the disclosure.

FIG. 2a is an illustration of the distal end an insertion tool withinner ridges according to one embodiment of the disclosure.

FIG. 2b is an illustration of a portion of the inner surface of thedistal end of an insertion tool with inner ridges according to oneembodiment of the disclosure.

FIG. 2c is an illustration of a portion of the inner surface of thedistal end of an insertion tool with inner ridges according to oneembodiment of the disclosure.

FIG. 2d is an illustration of the distal end an insertion tool withouter ridges according to one embodiment of the disclosure.

FIG. 2e is an illustration of a cross section of portion of a wall withinner and outer ridges according to one embodiment of the disclosure.

FIG. 2f is an illustration of a cross section of a portion of a wallwith inner and outer ridges according to one embodiment of thedisclosure.

FIG. 2g is an illustration of a cross section a wall according to oneembodiment of the disclosure.

FIG. 3a is an illustration of an insertion tool according to oneembodiment of the disclosure showing its proximal end.

FIG. 3b is an illustration of an insertion tool according to oneembodiment of the disclosure showing it distal end.

FIG. 4 is an illustration of an insertion tool according to oneembodiment of the disclosure, engaged with a hemostatic valve and aportion of a balloon catheter.

FIG. 5 is an illustration of an insertion tool according to oneembodiment of the disclosure showing its distal end.

FIG. 6 is an illustration of an insertion tool according to oneembodiment of the disclosure showing its proximal end along with aportion of a hemostatic valve.

FIGS. 7a-7c are illustrations of an insertion tool according to oneembodiment of the disclosure, along with a hemostatic valve and aportion of a balloon catheter.

FIGS. 8a-8d are illustrations of an insertion tool with a lockingmechanism, and portions thereof, according to one embodiment of thedisclosure, along with a portion of a balloon catheter.

FIGS. 9a-9e are illustrations of a method of inserting a ballooncatheter using an insertion tool with a locking mechanism, according toone embodiment of the disclosure

FIG. 10 is an illustration of an insertion tool having a telescopingfunction of, according to one embodiment of the disclosure.

FIGS. 11a and 11b are illustrations of an insertion tool with aperforated tapered distal end, according to one embodiment of thedisclosure, along with a portion of a balloon catheter.

FIGS. 12a-c are illustrations of an insertion article according to oneembodiment of the disclosure, along with a portion of a ballooncatheter.

DESCRIPTION

With reference to FIG. 1a , in one embodiment the disclosure provides aninsertion tool 10 having a tubular member 12 having a proximal 14 anddistal 16 ends. The tubular member has a first axis defining a lengthbetween the first and second ends.

Along the length of the tubular member 12 and between the proximal anddistal ends are two separation margins 20 a and 20 b (not shown in FIG.1a ; see FIG. 1b ), on opposite sides of the tubular member 12. Theseparation margins define first 22 and second 24 halves of the tubularmember 12. For example, each half of tubular member has a semicircularshape when viewed from one end as shown in FIG. 1 b.

As shown in greater detail in FIG. 1c , the separation margin can beformed by a groove 26 (or recess) in the wall of the tubular member 12.The groove causes the wall 25 of the tubular member to be thinnertowards its inner surface 27. The groove 26 can be deep enough in thewall that when force is applied to separate the first 22 and second 24halves, body member material along the separation margins fractures andthe two halves of the body member separate. In some embodiments theseparation margin can include perforations along its length.

Referring back to FIG. 1a , further, the tubular member can include afirst notch 28 a (second notch 28 b hidden from view) at the proximalend of the tubular member and in line with the separation margins. Thedistal end of the notch 28 can meet the proximal end of the separationmargin and is useful for fracturing the body member along the separationmargin in a proximal to distal direction when the two halves of the bodymember are pulled apart at the proximal end.

As shown in FIGS. 1a, 1b, 1d, and 1f , and at or near proximal end 14are attached to the tubular member first and second separation assistmembers (18 a, 18 b; 38 a, 38 b; 48 a, 48 b), which can be configured astabs. Referring to FIG. 1b , the tabs can have a shape that is narrowerat the point 30 were they attach to the tubular member, and are wider attheir outermost edge 32. Separation assist members facilitate theprocess of pulling apart the halves of the tubular member when the tabsare pulled in opposite directions. The tabs can be rigid such as shownin FIG. 1a and 1b , or can be bendable outwards and inwards, such asshown in FIGS. 1d and 1e . In order for the tabs be bendable, a groove(32 a, 32 b; 42 a, 42 b) can be present in the tab where it is attachedto the proximal end of the tool.

Separation assist members may be molded together with the body member(e.g., as a unitary construction), or may be formed as independentarticles and then attached to the outer surface of the body member atthe proximal end with an adhesive. FIG. 1d shows a tab that is attachedto the proximal end of the body member, and FIG. 1e show a tab having apartial radius to provide greater surface area contact with the outersurface of the tubular body member.

Referring to FIG. 1f , the insertion tool has a tapered end 34. Thetapered end can be formed by reducing the thickness of the wall oftubular member in a proximal to distal direction. The tubular member 12can have a constant inner diameter from the proximal to distal end.

In another embodiment, with reference to FIG. 2a , an insertion tool 110having a tubular member 112 is formed from a wall having an innersurface, wherein the inner surface includes a plurality of ridges 118.The ridges can run the length of the tubular member 112, from itsproximal 114 (not shown) to distal 116 end. In a related embodiment,with reference to FIG. 2d , an insertion tool 210 includes a tubularmember 212 formed from a wall having an outer surface that includes aplurality of ridges 218. The ridges can run the length of the tubularmember 212, from its proximal 214 (not shown) to distal 216 end.Alternatively ridges 218 can be strategically placed along the tubularmember 212 where contact with an insertable medical is anticipated, forexample, at tapered portions of the tubular member 212.

As shown in greater detail in FIGS. 2b and 2c , the ridges 118 candefine areas of the wall having a first thickness, wherein the firstthickness is represented by dashed line 125. The first thickness can bethe distance from the peak 122 (which may also be referred to as an“apex” or “tip”) of a ridge 118 to the outer surface 128 of the wall ofthe tubular member 112, which can represent the thickest portion of thewall. Between the ridges are areas of the wall having a secondthickness, which is the distance from the base 124 between the ridges tothe outer surface 128 of the wall of the tubular member 112, andrepresented by dashed line 127. This second thickness can represent thethinnest portions of the wall. These parameters can also be understoodfor the embodiments as shown in FIGS. 2d -2 f.

The first thickness is greater than the second thickness, and thereforeless material of the wall is present between the base and the outersurface of the tubular member. Because the material of the wall is thinbetween the ridges, it allows the tubular member to be fractured alongthe length of the wall between the ridges when outward forces areapplied to each half of the tubular member.

In some aspects, a relationship between the first thickness and thesecond thickness (e.g., lengths 125 and 127) can be defined by a ratiobetween the two. For example, an exemplary ratio of thickness can be inthe range of about 10:1 (first thickness:second thickness) to about 1:2,or about 5:1 to about 1:1, such as about 2:1 in an exemplary embodiment.Increasing the ratio of thickness (first thickness:second thickness) mayincrease the “fracturability” of the material between the ridges,allowing the tubular member to be readily split when outward forces areapplied to each half the tubular member. These parameters can also beapplied to the embodiments as shown in FIGS. 2d -2 f.

On the inner surface of the walls, the ridges can be configured to haveany suitable shape. For example, as shown in the FIGS. 2a-c , the ridgescan have an “upside-down V” shape, with the point of the “V”representing the peak 122. However, as an alternative to a pointed shapeat the peak of the ridge, the peak can be rounded or flat. For example,the ridges can have an “upside-down U” shape. These shapes can also bepresent in the embodiments as shown in FIGS. 2d -2 f.

The inner surface can include a desired number of ridges about thecircumference of its inner surface. The number of ridges that arepresent around the circumference can be determined by various factors,such as the shape and configuration of the ridges, the first and secondthicknesses, the inner diameter of the tubular member, and the desiredspacing between the ridges. In some configurations, the ridges areadjacent to one another, such as shown in FIGS. 2a-c . Alternatively,the spacing between the ridges can be greater so the area of the thinnerportions of the wall (second thickness) of the tubular member isincreased. These shapes and arrangements can also be present in theembodiments as shown in FIGS. 2d -2 f.

The configuration of the inner surface of the tubular member can also beof benefit as it reduces the area of contact between the inner wall andthe surface of a medical device that is movable within the member. Thatis, the peaks 122 of the ridges are the only areas of the inner surfacethat contact the surface of the medical device which in turn minimizesany frictional effect on the surface of the medical device that iscaused by the inner surface.

In some embodiments, the insertion tool has a tubular member thatincludes a plurality of ridges on both the inner and outer surfaces ofthe tubular member. FIG. 2e illustrates a portion of the wall of thetubular member having inner ridges 228 and outer ridges 238. A tubularmember with inner 228 and outer ridges 238 can be constructed so theirpeaks (inner peak 222 and outer peak 232) are substantially or fullyradially aligned with each other (i.e., the ridges fall along the sameradial line RL emanating from the center of the tubular member). Innerand outer ridges may be aligned over a portion of the circumference ofthe tubular member, or over the entire circumference of the tubularmember. When a series of inner and outer ridges are radially alignedwith each other, the inner ridges may have smaller dimensions, as thecircumference defined by the inner base points is smaller than thecircumference defined by the outer base points. Accordingly, thedistance between two base points defining an inner ridge can be lessthan the distance between two base points defining an outer ridge.Between the inner 228 and outer ridges 238 are areas of the wall havinga thickness, which is the distance from the inner base 224 to the outerbase 234, and represented by dashed line 227. The tubular member may beeasily fractured along dashed line 227 when outward forces are appliedto each half the tubular member given the minimal thickness of the wallat this location.

In other embodiments and with reference to FIG. 2f , inner ridges 248and outer ridges 258 are not radially aligned with each other over atleast a portion of the circumference of the tubular member. In yet otherembodiments, the insertion tool has a tubular member that includes oneor more groups of ridges on both the inner and outer surfaces of thetubular member that are radially aligned with each other, and also oneor more groups of ridges on both the inner and outer surfaces of thetubular member that are not radially aligned with each other. Forexample, and with reference to FIG. 2g , the tubular member can includetwo groups of ridges (group 221 and group 231) that are aligned witheach other wherein these groups are on opposite sides of the tubularmember, and the remaining inner and outer ridges between group 221 andgroup 231 are not aligned with each other. In this arrangement the wallthickness in the area defined by groups 221 and 231 can be less than thewall thickness in the areas outside these groups, and when outwardforces are applied to each half the tubular member is more likely tofracture in the area defined by groups 221 and 231.

The insertion tool 110 with a plurality of ridges 118 can also includeand at or near it proximal end (not shown) first and second separationassist members (such as shown with reference to FIGS. 1a, 1b, 1d, and 1e, elements 18 a, 18 b; 38 a, 38 b; 48 a, 48 b), which can be configuredas tabs. An insertion tool 110 with a plurality of ridges 118 can alsoinclude at its proximal end notches useful for fracturing the bodymember along the lines of the body member between the ridges, such asshown with reference to FIGS. 1a , elements 28 a and 28 b).

With reference to FIGS. 3a and 3b , and in another embodiment, thedisclosure provides an insertion tool 50 having a tubular member 52having a proximal end 54 and a distal end 56, with openings 58 and 60,respectively. Distal opening 60 has an inner diameter of a sizesufficient to allow a balloon portion of a balloon catheter to movethrough it. For example, in embodiments the inner diameter at the distalopening can be at least about 2.25 mm, such as in the range of about 2.5mm to about 7.5 mm, or about 3 mm to about 6 mm. The tubular member candefine a central axis CA along the length of the member from theproximal to distal end.

Proximal opening 58 has an inner diameter that is larger than the innerdiameter of the distal opening 60. For example, in embodiments the innerdiameter at the proximal opening can be at least about 3 mm, such as inthe range of about 3.5 mm to about 10 mm, or about 4 mm to about 8 mm.

The insertion tool also includes a flange 62 arranged about the outerdiameter of the proximal end. The flange can be in the form of acircular rim, which can be at an angle to the central axis CA of thetubular member, such in the range of about 75° to about 105° the centralaxis, preferably about 90° to the central axis. The flange may have adiameter measured relative to the outer diameter of the proximal end ofthe tube, such as a diameter that is in the range of about 1.1× to about3× the outer diameter of the proximal end of the tubular member, such ain the range of about 1.5× to about 2.5×.

Since the distal opening is smaller than the proximal opening, thisprovides the tubular member with a tapered configuration. Further, thealong with the tapered configuration, the presence of the flange 62arranged about the outer diameter of the proximal end provides theinsertion tool with a “cone” shape.

In use, and with reference to FIG. 4, the insertion tool can be used inconjunction with a hemostatic valve to facilitate the entry of a ballooncatheter into an artery. The hemostatic valve 63 can have a proximal 64and distal 66 openings, the distal opening adapted to enter an artery.The distal end of the insertion tool 50 is moved into the proximalopening 64 of the hemostatic valve and out its distal opening 66, so thedistal end 56 of the insertion tool 50 is within the artery. The flange62 of the insertion tool 50 can be held between two fingers andtherefore useful for moving the insertion tool in and out of thehemostatic valve. As the tubular member 52 of the insertion tool 50increases in diameter towards its proximal end 54, it engages and sealswith the inner surface of the hemostatic valve 63, generally near or atthe proximal end 54 of the insertion tool. The flange 62 can also serveas a stop to the proximal movement of the tubular member 52 in thehemostatic valve 63, where the distal face 61 of the flange 62 may abutthe proximal face of the hemostatic valve 63.

A balloon catheter 70 can be moved through the insertion tool 50 whichfacilitates its entry into an artery. In one mode of practice, theballoon end 72 of the balloon catheter 70 can be placed within theinsertion tool prior to attachment to the hemostatic valve 63, and thenthe distal end 56 of the insertion tool, along with the balloon portion74 of the balloon catheter 70, can be moved into the hemostatic valve63. After the insertion tool is sufficiently engaged with the hemostaticvalve the balloon catheter can be advanced to move it into the artery toa treatment site.

In another mode of practice, the insertion tool 50 is first attached tothe hemostatic valve 63 prior to introducing the balloon catheter 70.For example, the distal end 56 of the insertion tool, without theballoon catheter 70, can be moved into and sufficiently engaged with thehemostatic valve 63. Next, the balloon end 72 of the balloon catheter 70can be placed within the insertion tool 50 that is engaged with thehemostatic valve 63 and then advanced through the insertion tool 50 toan artery to a treatment site.

With reference to FIG. 5, and in another embodiment, the disclosureprovides an insertion tool 80 having first elongate member 82 and secondelongate member 84. The first elongate member 82 has a distal portion 85with distal end 86, and likewise the second elongate member 84 has adistal portion 87 with distal end 88. The distal portion of eachelongate member has an arcuate shape that provides the distal portionwith a trough-like configuration. For example, the distal portion canhave a configuration that resembles a half-diameter of a tube. Thearcuate shape of the elongate member can be a portion of a circle or anoval, and can be about 180° or less, such as in the range of about 90°to about 180°. The same arcuate shape of the distal portion can extendproximally towards the proximal portion, or the arcuate shape can changetowards the distal portion, for example the elongated member canflatten.

The first elongate member 82 also has a proximal portion 95 with tab 96,and likewise the second elongate member 84 has a proximal portion 97with tab 98. Tabs 96 and 98 can be at an angle to the proximal portionsof the elongate members. That is, the tab of an elongate portion can bedirected away from the central cavity of the tool, such as an angle fromabout 30° to about 90° from the distal portion of the elongate member.

The insertion tool includes a set of hinges (i.e., first hinge 92 andsecond hinge 94) that attach the first elongate member 82 to the secondelongate member 84. The hinges can be attached to inward protrusions(102, 104) from the first and second elongate members between the tab ofthe proximal portion, and the distal portion. The set of hinges can biasthe distal ends of the first and second elongate members towards eachother. For example, the set of hinges can be a set of springs or coilsthat maintains force between the distal ends of the first and secondelongate members. The distal ends of the first and second elongatemembers can be moved apart by applying pressure to the tabs, such as bysqueezing the tabs together. This results in the opening of the distalend of the insertion tool and can provide a passageway from the proximalend, between the tabs, to the distal end.

For example, and with reference to FIG. 6, in a method of using thedistal ends of the first and second elongate members of the insertiontool can be placed within an opening of a hemostatic valve 103, such asa silicone valve. The tabs 96 and 98 can be depressed, causing thedistal ends to spread apart, and forcing the material of the valve towiden. At this point, the distal end of a balloon catheter can be movedthrough the inner portion of the insertion tool, from the proximal end,though the distal portion, and into the hemostatic valve 103.

FIG. 7a shows a balloon catheter 110 with balloon portion 114, theinsertion tool 80, and a hemostatic valve 103 on an artery. Referring toFIG. 7b , the balloon end 112 is advanced proximally into the insertiontool between the distal portions of the first elongate member 82 andsecond elongate member 84. Next, referring to FIG. 7c , the distal endof the insertion tool 80 is inserted into an opening of a hemostaticvalve 103, and then the distal ends of the first and second elongatemembers are moved apart in the valve 103 by applying pressure to thetabs, causing the opening of the valve to widen, allowing easy entry ofthe balloon end 112 of the balloon catheter 110.

With reference to FIGS. 8a-8c , and in another embodiment, thedisclosure provides an insertion tool 130 having an elongate hollow body131 having a proximal end 133 and distal end 135. The elongate hollowbody is tapered at its distal end 135. For example, the diameter of theelongate hollow body 131 can decrease over a portion of its length toprovide a distal end 135 with an opening that can allow passage of aballoon portion of a balloon catheter in a folded uninflated state 145.In exemplary designs, the proximal portion of the elongate hollow body131 has an outer diameter in the range of about 2.4 cm to about 2.7 cm,which then tapers towards the distal end 135 which has an outer diameterin the range of about 2.2 cm to about 2.4 cm. The insertion tool 130also can include a locking mechanism 137 located at the proximal end ofthe elongate hollow body 131.

FIG. 8a shows the insertion tool 130 and portions of a balloon catheterthat are the guidewire 143 and the distal tip 141 of the balloon. Theballoon catheter is held in place within the elongate hollow body 131. Aballoon catheter can be supplied to a user with the balloon cathetermounted in the insertion tool 130, or the insertion tool can be providedseparately from the balloon catheter, and the balloon catheter mountedprior to the insertion procedure.

The distal portion of the insertion tool 130 can be tapered towards itsdistal end. The opening at the distal end can be sized to fit the tip ofthe balloon, which can position and stabilize the balloon catheter alongthe central axis of the elongate hollow body 131.

FIG. 8b is a cross-sectional illustration of insertion tool 130 at plane“A” (with reference to FIG. 8A), showing the distal tip 141 of theballoon catheter loaded in the elongate hollow body 131 viewed from thedistal end of the tool. The balloon tip 141 and guidewire 143 are showncentered along a central axis, the central axis within and extendingfrom the distal to proximal end of the elongate hollow body 131.

FIG. 8c is a cross-sectional illustration of insertion tool 130 at plane“B” (with reference to FIG. 8A), showing the balloon catheter loaded inthe elongate hollow body 131 at viewed from proximal end of the tool.The balloon portion of the balloon catheter is shown in an uninflatedfolded configuration, including multiple flaps 145 of the balloon foldedon each other in a circumferential manner. At least at this location,the outermost portion of the flaps 145 of the balloon that are furthestfrom the central axis (e.g., guidewire 143) are spaced away from theinner surface of the wall 136 of the elongate hollow body 131.

The locking mechanism 137 can be mechanically actuated to apply pressureto a part of the balloon catheter along its length (such as a portion,like the guidewire, that is proximal to the balloon portion) to securethe balloon catheter within the insertion tool 130. Securing the ballooncatheter can prevent its movement relative to the elongate hollow bodyin a proximal to distal direction, and can accordingly maintain theballoon portion of the catheter centered within the hollow elongate bodyduring an insertion procedure.

An exemplary locking mechanism is shown in FIG. 8d , which is a view ofthe insertion tool 130 from its proximal end. The locking mechanism 137is attached to the proximal end of the elongate hollow body 131. In onearrangement the locking mechanism 137 includes a ring 144 that isrotatable in clockwise (C) and counterclockwise (CC) directions totighten and loosen the locking mechanism 137.

Within the ring 144 can be a diaphragm-type of valve (e.g., an irisvalve) that provides an opening 139 in the center of the lockingmechanism through which a portion of the balloon catheter (not shown)can be placed. The size of the opening 139 can be changed by rotation ofthe ring, which causes movement of leaves 138. For example, theguidewire can be placed through the opening 139, and then the ring 144can be rotated in direction C to cause leaves 138 of the valve to move,contact, and apply pressure to the circumference of the outer surface ofthe guidewire (not shown), thereby securing the balloon catheter.

Exemplary steps of a method of inserting a balloon catheter using theinsertion tool 130 are shown in FIGS. 9A-9E. FIG. 9A shows the insertiontool 130 with a balloon portion of a balloon catheter (not shown)disposed and secured within the elongate hollow body. Shown are theproximal 143 a and distal ends 143 b of the guidewire, and the distaltip 141 of the balloon portion of the catheter, which extends distallybeyond the distal end 135 of the elongate hollow body. The distalportion 143 b of the guidewire is shown as disposed through an insertionsite 150 and within a patient. The locking mechanism 137 can be in alocked position which causes movement of the entire balloon catheter,including the guidewire and balloon portion, when the insertion tool ismoved. FIG. 9B shows that the insertion tool 130 is moved to provide thetip 141 of the balloon portion (not shown) of the balloon catheter inthe insertion site 150. FIG. 9C shows that the distal tapered end 149 ofthe insertion tool 130 is continued to advance through the insertionsite 150, which can widen the insertion site while protecting theballoon from contact with the insertion site 150 as the device isadvanced through this location. After at least a portion of the taperedend 149 is in the insertion site 150, the locking mechanism 137 isloosened. As a result, for example, the guidewire 143 a can becomeunclamped and the entire balloon catheter can be allowed to move freelyin relation to the insertion tool 130. FIG. 9D shows the balloon portion155 of the balloon catheter can then be moved distally, out of theelongate hollow body 131 and beyond the distal end of the insertion tool130. FIG. 9E shows the insertion tool 130 can then be moved in aproximal direction to withdraw it from the insertion site 150. Theballoon portion 155 can then be advanced to the target site forperforming treatment (e.g., balloon angioplasty).

Optionally, the insertion tool as show in FIGS. 8a-8d (optionally usedaccording to the illustrations in FIGS. 9a-9e ), can include one or morefeatures according to features the insertion tools shown in FIGS. 10, 11a, and/or 11 b. For example, the insertion tool with the lockingmechanism can further include two or more elongate hollow bodies thatare slidably disposed with one another, such as a first distal bodyhaving a tapered end that can hold the balloon tip, which can beslidable within a second proximal elongate hollow body having a lockingmechanism at its proximal end. The distal tip of the insertion tool withthe locking mechanism can also be configured to split apart uponapplication of force to provide a larger opening, and may include two ormore perforations, slits, or thinned areas of the wall of the tapereddistal end.

With reference to FIG. 10, and in another embodiment, the disclosureprovides an insertion tool 160 having a first elongate hollow body 162that is slidably movable within an inner diameter of a second elongatebody 164. That is, the first and second bodies can provide a“telescoping”-like functionality, where the first body 162 can bepartially or completely slid into the inner diameter of the second body164. Although two elongate hollow bodies are shown, the insertion toolcan include one or more additional elongate hollow bodies which can beslidably movable in relation to the first and second bodies. The firsthollow body 162 includes an opening 165 sized to accommodate and allowthe passage of a balloon portion 167 of a balloon catheter when theballoon portion 167 is in a folded uninflated state. The first elongatehollow body 162 may also have a tapered distal end for ease ofinsertion.

Insertion tool 160 can be used in a method for introducing a ballooncatheter into a patient's body, where the balloon catheter is initiallydisposed within the first elongate hollow body. In the method, theinsertion tool 160 with the balloon portion of a balloon catheter loadedinto the first elongate hollow body. The distal end of the firstelongate hollow body is introduced in the patient's body, and then theballoon catheter is moved distally out of the first elongate hollow bodyinto the patient. The first elongate hollow body is them movedproximally out of the patient's body. At one or more points during themethod the first elongate hollow body is moved in relation to the secondelongate hollow body. For example, prior to introducing the distal endinto the patient, the first elongate hollow body can be fully orpartially disposed within the second elongate body, and then uponintroduction of the distal end, the first elongate hollow body is moveddistally out of the second elongate hollow body. After the distal end ofthe first elongate hollow body is within the patient, it may be movedproximally and into the second elongate hollow body to expose theballoon portion of the balloon catheter in the patient. The firstelongate hollow body many also be moved proximally and into the secondelongate hollow body to completely withdraw the distal end of the firstelongate hollow body from the patient. Once delivery of the balloonportion 167 is complete, the elongate hollow bodies 162, 164 can beslidably collapsed (telescoped) and removed proximally to the insertiondevice. One advantage of the collapsed hollow bodies 162, 164 can bethat the insertion tool 160 occupies less space proximally on themedical device, allowing for less encumbered activities by the medicalprofessional.

Optionally, the insertion tool as show in FIG. 10 can include one ormore features according to features the insertion tools shown in FIGS.8a-8d, 11a, and/or 11b . For example, the insertion tool with thetelescoping mechanism can further include a locking mechanism, such asshown in FIG. 8d , at the proximal end of the second elongate hollowbody. The insertion tool with the telescoping mechanism can furtherinclude a distal tip on the distal end of the first elongate hollow bodyconfigured to split apart upon application of force to provide a largeropening, and may include two or more perforations, slits, or thinnedareas of the wall of the tapered distal end.

In some embodiments, the insertion tool has a tapered distal end that isable to be split open upon application of force to provide an opening ofa greater size that facilitates movement of the balloon portion of theballoon catheter out of the distal end. The distal tip can be preparedto provide one or more areas of material weakness which can facilitatethe splitting of the distal tip. For example, these areas may includeperforations, slits, or thinned areas of the wall of the tapered distalend.

As an example and with reference to FIG. 11a , in this embodiment of thedisclosure an insertion tool 170 having an elongate hollow body 172comprising a tapered distal end 174 comprising an opening 176 and two ormore perforations (178 a, 178 b not shown) is provided. The tapered endcan be split open along the perforations to increase the size of theopening and allow for passage of a balloon catheter.

For example, in a method for introducing a balloon catheter into apatient's body, the insertion tool 170 is first provided with theelongate hollow body 172 housing a balloon portion of a ballooncatheter. The tapered distal end 174 of the elongate hollow body isintroduced into the patient's body. With reference to FIG. 11b , thetapered end is forced to be split open along the perforations toincrease the size of the opening and allow for passage of a ballooncatheter 179 which can be moved distally out of the opening at the splitdistal end.

Optionally, the insertion tool as show in FIGS. 11a and 11b can includeone or more features according to features the insertion tools shown inFIGS. 8a-8d , and 10. For example, the insertion tool with the tapereddistal end with one or more areas of weakness can include a lockingmechanism, such as shown in FIG. 8d , at the proximal end of theelongate hollow body. As another example, the insertion tool with thetapered distal end with one or more areas of weakness can furtherinclude two or more elongate hollow bodies that are slidably disposedwith one another, such as a first distal body having a tapered end,which can be slidable within a second proximal elongate hollow body.

In another embodiment, the disclosure provides an insertion article forfacilitating the entry of a balloon catheter into the body, wherein theinsertion article is formed of a pliable material having interior andexterior surfaces that are continuous with each other and that can bemoved around a liquid or gel 185 that is encompassed by the pliablematerial. An example of the insertion article is shown in FIG. 12a ,which is a cross-sectional view of the tubular article 180 with outersurface 181 and inner surface 182. The inner surface 182 defines acavity 186 between the proximal 183 and distal ends 184 of the article.

The article generally has an elongate tubular shape, but the shape isnot dimensionally fixed because the article is formed of pliablematerial, such as a thin plastic material that surrounds a liquid or gelcenter. Because of its tubular shape and continuous surface, the outerand inner surfaces are able to be moved around the liquid or gel whilethe article is stationary. FIG. 12A shows that the pliable material canbe pulled on its outer surface in a proximal direction, and then pushedon its inner surface in a distal direction to affect movement of thepliable material according to the arrows. An object placed within thecavity can be moved in a proximal to distal direction when the pliablematerial forming the surfaces is moved in such a manner.

For example, as shown in FIG. 12B the balloon portion 188 of a ballooncatheter can be positioned in the cavity 186 of the insertion article.The distal end of the insertion article can be placed at an insertionsite. The pliable material can then be manipulated to affect movement ofthe pliable material according to the arrows, which in turn moves theballoon catheter in the distal direction. The balloon portion 188 of theballoon catheter enters the insertion site as shown the insertionarticle can then be withdrawn from the site, as shown in FIG. 12C.

In embodiments of the disclosure, any portion of any insertiontool/article, or any portions of catheter of the disclosure can have acoating, such as a hydrophilic lubricious coating. For example,hydrophilic polymeric base coatings can be applied to portions of theinsertion tool/article, or any portions of catheter to impart lubricityand decrease particulate shedding. In some examples, portions of thevalve on the distal end of the sleeve are covered with a coating. Inother examples, the inner diameter of the sleeve is coated or lined withlubricious low friction coatings or the outer diameter is lined withlubricious low friction coatings, friction reducing or lubricatingmaterials such as silicone oil, perfluorinated oils or waxes or withcovalently bonded coating that imparts lower friction.

Exemplary embodiments of low friction surfaces for the vascular accessdevices described herein include substrates prepared from low frictionmaterials (e.g. PTFE and PTFE liners) and surfaces that can be made tobe low friction by addition of coatings (e.g. coatings with hydrophilicpolymers).

One class of hydrophilic polymers useful as polymeric materials forhydrophilic base coat formation can be synthetic hydrophilic polymers.Synthetic hydrophilic polymers that are biostable (i.e., that show noappreciable degradation in vivo) can be prepared from any suitablemonomer including acrylic monomers, vinyl monomers, ether monomers, orcombinations of any one or more of these types of monomers. Acrylicmonomers include, for example, methacrylate, methyl methacrylate,hydroxyethyl methacrylate, hydroxyethyl acrylate, methacrylic acid,acrylic acid, glycerol acrylate, glycerol methacrylate, acrylamide,methacrylamide, dimethylacrylamide (DMA), and derivatives and/ormixtures of any of these. Vinyl monomers include, for example, vinylacetate, vinylpyrrolidone, vinyl alcohol, and derivatives of any ofthese. Ether monomers include, for example, ethylene oxide, propyleneoxide, butylene oxide, and derivatives of any of these. Examples ofpolymers that can be formed from these monomers includepoly(acrylamide), poly(methacrylamide), poly(vinylpyrrolidone),poly(acrylic acid), poly(ethylene glycol), poly(vinyl alcohol), andpoly(HEMA). Examples of hydrophilic copolymers include, for example,methyl vinyl ether/maleic anhydride copolymers and vinylpyrrolidone/(meth)acrylamide copolymers. Mixtures of homopolymers and/orcopolymers can be used.

Examples of some acrylamide-based polymers, such aspoly(N,Ndimethylacrylamide-co-aminopropylmethacrylamide) andpoly(acrylamide-co-N,Ndimethylaminopropylmethacrylamide) are describedin example 2 of U.S. Pat. No. 7,807,750 (Taton et al.), the disclosureof which is incorporated herein by reference.

Other hydrophilic polymers that can be useful in the present disclosureare derivatives of acrylamide polymers with photoreactive groups. Onesuch representative hydrophilic polymer can be the copolymerization ofN-[3-(4-benzoylbenzamido)propyl]methacrylamide (Formula I) withN-(3-aminopropyl)methacrylamide (Formula II) to produce the polymerpoly(N-3-aminopropyl)methacrylamide-co-N-[3-(4-benzoylbenzamido)propyl]methacrylamide (Formula III). Thepreparation of the polymer is disclosed in Example 1 of US PatentPublication 2007/0032882 (to Lodhi, et al.), the full content of whichis incorporated herein by reference.

In some embodiments, the hydrophilic polymer can be a vinyl pyrrolidonepolymer, or a vinyl pyrrolidone/(meth)acrylamide copolymer such aspoly(vinylpyrrolidone-co-methacrylamide). If a PVP copolymer is used, itcan be a copolymer of vinylpyrrolidone and a monomer selected from thegroup of acrylamide monomers. Exemplary acrylamide monomers include(meth)acrylamide and (meth)acrylamide derivatives, such asalkyl(meth)acrylamide, as exemplified by dimethylacrylamide, andaminoalkyl(meth)acrylamide, as exemplified by aminopropylmethacrylamideand dimethylaminopropylmethacrylamide. For example,poly(vinylpyrrolidone-co-N,N-dimethylaminopropylmethacrylamide) isdescribed in example 2 of U.S. Pat. No. 7,807,750 (Taton et al.).

In one embodiment, the polymers and copolymers as described arederivatized with one or more photoactivatable group(s). Exemplaryphotoreactive groups that can be pendent from biostable hydrophilicpolymer include aryl ketones, such as acetophenone, benzophenone,anthraquinone, anthrone, quinone, and anthrone-like heterocycles. Arylketones herein can specifically include diaryl ketones. Polymers hereincan provide a hydrophilic polymer having a pendent activatablephotogroup that can be applied to the expandable and collapsiblestructure, and can then treated with actinic radiation sufficient toactivate the photogroups and cause covalent bonding to a target, such asthe material of the expandable and collapsible structure. Use ofphoto-hydrophilic polymers can be used to provide a durable coating of aflexible hydrogel matrix, with the hydrophilic polymeric materialscovalently bonded to the material of the expandable and collapsiblestructure.

A hydrophilic polymer having pendent photoreactive groups can be used toprepare the flexible hydrogel coating. Methods of preparing hydrophilicpolymers having photoreactive groups are known in the art. For example,methods for the preparation of photo-PVP are described in U.S. Pat. No.5,414,075, the disclosure of which is incorporated herein by reference.Hydrophilic photo-polyacrylamide polymers such aspoly(acrylamide-co-N-(3-(4-benzoylbenzamido)propyl) methacylamide),“Photo PA”, and derivatives thereof can be used to form hydrophilic basecoats in exemplary embodiments of the present disclosure. Methods forthe preparation of photo-polyacrylamide are described in U.S. Pat. No.6,007,833, the disclosure of which is incorporated herein by reference.

Other embodiments of hydrophilic base coats include derivatives ofphoto-polyacrylamide polymers incorporating additional reactivemoieties. Some exemplary reactive moieties include N-oxysuccinimide andglycidyl methacrylate. Representative photo-polyacrylamide derivativesincorporating additional reactive moieties includepoly(acrylamide-co-maleic-6-aminocaproicacid-N-oxysuccinimide-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)andpoly(acrylamide-co-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-glycidylmethacrylate.Additional photo-polyacrylamide polymers incorporating reactive moietiesare described in U.S. Pat. No. 6,465,178 (to Chappa, et al.), U.S. Pat.No. 6,762,019 (to Swan, et al.) and U.S. Pat. No. 7,309,593 (to Ofstead,et al.), the disclosures of which are herein incorporated by reference.

Other embodiments of exemplary hydrophilic base coats that includederivatives of photo-polyacrylamide polymers incorporating additionalreactive moieties can be found in U.S. Pat. No. 6,514,734 (to Clapper,et al.), the disclosure of which is incorporated herein by reference inits entirety.

In yet other embodiments, the hydrophilic base coat can includederivatives of photo-polyacrylamide polymers incorporating chargedmoieties. Charged moieties include both positively and negativelycharged species. Exemplary charged species include, but are not limitedto, sulfonates, phosphates and quaternary amine derivatives. Someexamples include the negatively charged species N-acetylatedpoly(acrylamide-co-sodium-2-acrylamido-2-methylpropanesulfonate-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-methoxypoly(ethylene glycol) monomethacrylate. Other negatively charged speciesthat can be incorporated into the hydrophilic base coat are described inU.S. Pat. No. 4,973,993, the disclosure of which is incorporated hereinby reference in its entirety. Positively charged species can includepoly(acrylamide-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-(3-(methacryloylamino)propyl)trimethylammoniumchloride. Other positively charged species that can be incorporated intothe hydrophilic base coat are described in U.S. Pat. No. 5,858,653 (toDuran et al.), the disclosure of which is incorporated herein byreference in its entirety.

In another embodiment, the polymers and copolymers as described arederivatized with one or more polymerizable group(s). Polymers withpendent polymerizable groups are commonly referred to as macromers. Thepolymerizable group(s) can be present at the terminal portions (ends) ofthe polymeric strand or can be present along the length of the polymer.In one embodiment polymerizable groups are located randomly along thelength of the polymer.

Exemplary hydrophilic polymer coatings can be prepared using polymergrafting techniques. Polymer grafting techniques can include applying anonpolymeric grafting agent and monomers to a substrate surface thencausing polymerization of the monomers on the substrate surface uponappropriate activation (for example, but not limited to, UV radiation)of the grafting agent. Grafting methods producing hydrophilic polymericsurfaces are exemplified in U.S. Pat. Nos. 7,348,055; 7,736,689 and8,039,524 (all to Chappa et al.) the full disclosures of which areincorporated herein by reference.

Optionally, the coating can include a crosslinking agent. A crosslinkingagent can promote the association of polymers in the coating, or thebonding of polymers to the coated surface. The choice of a particularcrosslinking agent can depend on the ingredients of the coatingcomposition.

Suitable crosslinking agents can include two or more activatable groups,which can react with the polymers in the composition. Suitableactivatable groups can include photoreactive groups as described herein,like aryl ketones, such as acetophenone, benzophenone, anthraquinone,anthrone, quinone, and anthrone-like heterocycles. A crosslinking agentincluding a photoreactive group can be referred to as aphoto-crosslinker or photoactivatable crosslinking agent. Thephotoactivatable crosslinking agent can be ionic, and can have goodsolubility in an aqueous composition. Thus, in some embodiments, atleast one ionic photoactivatable crosslinking agent can be used to formthe coating. The ionic crosslinking agent can include an acidic group orsalt thereof, such as selected from sulfonic acids, carboxylic acids,phosphonic acids, salts thereof, and the like. Exemplary counter ionsinclude alkali, alkaline earths metals, ammonium, protonated amines, andthe like.

Exemplary ionic photoactivatable crosslinking agents include4,5-bis(4-benzoylphenylmethyleneoxy) benzene-1,3-disulfonic acid orsalt; 2,5-bis(4-benzoylphenylmethyleneoxy)benzene-1,4-disulfonic acid orsalt; 2,5-bis(4-benzoylmethyleneoxy)benzene-1-sulfonic acid or salt;N,N-bis[2-(4-benzoylbenzyloxy)ethyl]-2-aminoethanesulfonic acid or salt,and the like. See U.S. Pat. No. 6,077,698 (Swan et al.), U.S. Pat. No.6,278,018 (Swan), U.S. Pat. No. 6,603,040 (Swan) and U.S. Pat. No.7,138,541 (Swan) the disclosures of which are incorporated herein byreference.

Other exemplary ionic photoactivatable crosslinking agents includeethylenebis(4-benzoylbenzyldimethylammonium) dibromide andhexamethylenebis(4-benzoylbenzyldimethylammonium) dibromide and thelike.

See U.S. Pat. No. 5,714,360 (Swan et al.) the disclosures of which areincorporated herein by reference.

In yet other embodiments, restrained multifunctional reagents withphotoactivable crosslinking groups can be used. In some examples theserestrained multifunctional reagents include tetrakis (4-benzoylbenzylether) of pentaerthyritol and the tetrakis (4-benzoylbenzoate ester) ofpentaerthyritol. See U.S. Pat. No. 5,414,075 (Swan et al.) and U.S. Pat.No. 5,637,460 (Swan et al.) the disclosures of which are incorporatedherein by reference.

Additional crosslinking agents can include those having formulaPhoto1-LG-Photo2, wherein Photo1 and Photo2 independently represent atleast one photoreactive group and LG represents a linking groupcomprising at least one silicon or at least one phosphorus atom, whereinthe degradable linking agent comprises a covalent linkage between atleast one photoreactive group and the linking group, wherein thecovalent linkage between at least one photoreactive group and thelinking group is interrupted by at least one heteroatom. See U.S. Pat.No. 8,889,760 (Kurdyumov, et al.), the disclosure of which isincorporated herein by reference. Further crosslinking agents caninclude those having a core molecule with one or more charged groups andone or more photoreactive groups covalently attached to the coremolecule by one or more degradable linkers. See U.S. Publ. Pat. App. No.2011/0144373 (Swan, et al.), the disclosure of which is incorporatedherein by reference.

Crosslinking agents used in accordance with embodiments herein caninclude those with at least two photoreactive groups. Exemplarycrosslinking agents are described in U.S. Pat. No. 8,889,760, thecontent of which is herein incorporated by reference in its entirety.

In some embodiments, the first and/or second crosslinking agent can havea molecular weight of less than about 1500 kDa. In some embodiments thecrosslinking agent can have a molecular weight of less than about 1200,1100, 1000, 900, 800, 700, 600, 500, or 400.

In some embodiments, at least one of the first and second crosslinkingagents comprising a linking agent having formula Photo1-LG-Photo2,wherein Photo1 and Photo2, independently represent at least onephotoreactive group and LG represents a linking group comprising atleast one silicon or at least one phosphorus atom, there is a covalentlinkage between at least one photoreactive group and the linking group,wherein the covalent linkage between at least one photoreactive groupand the linking group is interrupted by at least one heteroatom.

In some embodiments, at least one of the first and second crosslinkingagents comprising a linking agent having a formula selected from:

wherein R1, R2, R8 and R9 are any substitution; R3, R4, R6 and R7 arealkyl, aryl, or a combination thereof; R5 is any substitution; and eachX, independently, is O, N, Se, S, or alkyl, or a combination thereof;

wherein R1 and R5 are any substitution; R2 and R4 can be anysubstitution, except OH; R3 can be alkyl, aryl, or a combinationthereof; and X, independently, are 0, N, Se, S, alkylene, or acombination thereof;

wherein R1, R2, R4 and R5 are any substitution; R3 is any substitution;R6 and R7 are alkyl, aryl, or a combination thereof; and each X canindependently be O, N, Se, S, alkylene, or a combination thereof; and

In a particular embodiment, the crosslinking agent can bebis(4-benzoylphenyl) phosphate.

In some embodiments, the photoactivatable crosslinking agent can beionic, and can have good solubility in an aqueous composition, such asthe first and/or second coating composition. Thus, in some embodiments,at least one ionic photoactivatable crosslinking agent is used to formthe coating. In some cases, an ionic photoactivatable crosslinking agentcan crosslink the polymers within the second coating layer which canalso improve the durability of the coating.

Any suitable ionic photoactivatable crosslinking agent can be used. Insome embodiments, the ionic photoactivatable crosslinking agent is acompound of formula I: X1-Y-X2 where Y is a radical containing at leastone acidic group, basic group, or a salt of an acidic group or basicgroup. X1 and X2 are each independently a radical containing a latentphotoreactive group. The photoreactive groups can be the same as thosedescribed herein. Spacers can also be part of X1 or X2 along with thelatent photoreactive group. In some embodiments, the latentphotoreactive group includes an aryl ketone or a quinone. The radical Yin formula I provides the desired water solubility for the ionicphotoactivatable crosslinking agent. The water solubility (at roomtemperature and optimal pH) is at least about 0.05 mg/ml. In someembodiments, the solubility is about 0.1 to about 10 mg/ml or about 1 toabout 5 mg/ml.

In some embodiments of formula I, Y is a radical containing at least oneacidic group or salt thereof. Such a photoactivatable crosslinking agentcan be anionic depending upon the pH of the coating composition.Suitable acidic groups include, for example, sulfonic acids, carboxylicacids, phosphonic acids, and the like. Suitable salts of such groupsinclude, for example, sulfonate, carboxylate, and phosphate salts. Insome embodiments, the ionic crosslinking agent includes a sulfonic acidor sulfonate group. Suitable counter ions include alkali, alkalineearths metals, ammonium, protonated amines, and the like.

For example, a compound of formula I can have a radical Y that containsa sulfonic acid or sulfonate group; X1 and X2 can contain photoreactivegroups such as aryl ketones. Such compounds include4,5-bis(4-benzoylphenylmethyleneoxy) benzene-1,3-disulfonic acid orsalt; 2,5-bis(4-benzoylphenylmethyleneoxy)benzene-1,4-disulfonic acid orsalt; 2,5-bis(4-benzoylmethyleneoxy)benzene-1-sulfonic acid or salt;N,N-bis[2-(4-benzoylbenzyloxy)ethyl]-2-aminoethanesulfonic acid or salt,and the like. See U.S. Pat. No. 6,278,018. The counter ion of the saltcan be, for example, ammonium or an alkali metal such as sodium,potassium, or lithium.

In other embodiments of formula I, Y can be a radical that contains abasic group or a salt thereof. Such Y radicals can include, for example,an ammonium, a phosphonium, or a sulfonium group. The group can beneutral or positively charged, depending upon the pH of the coatingcomposition. In some embodiments, the radical Y includes an ammoniumgroup. Suitable counter ions include, for example, carboxylates,halides, sulfate, and phosphate. For example, compounds of formula I canhave a Y radical that contains an ammonium group; X1 and X2 can containphotoreactive groups that include aryl ketones. Such photoactivatablecrosslinking agents include ethylenebis(4-benzoylbenzyldimethylammonium)salt;

hexamethylenebis (4-benzoylbenzyldimethylammonium) salt;1,4-bis(4-benzoylbenzyl)-1,4-dimethylpiperazinediium) salt,bis(4-benzoylbenzyl) hexamethylenetetraminediium salt,bis[2,-(4-benzoylbenzyldimethylammonio)ethyl]-4-benzoylbenzylmethylammoniumsalt; 4,4-bis(4-benzoylbenzyl)morpholinium salt;ethylenebis[(2-(4-benzoylbenzyldimethylammonio)ethyl)-4-benzoylbenzylmethylammonium]salt;and 1,1,4,4-tetrakis(4-benzoylbenzyl)piperzinediium salt. See U.S. Pat.No. 5,714,360. The counter ion is typically a carboxylate ion or ahalide. On one embodiment, the halide is bromide.

In other embodiments, the ionic photoactivatable crosslinking agent canbe a compound having the formula:

wherein X1 includes a first photoreactive group; X2 includes a secondphotoreactive group; Y includes a core molecule; Z includes at least onecharged group; D1 includes a first degradable linker; and D2 includes asecond degradable linker. Additional exemplary degradable ionicphotoactivatable crosslinking agents are described in US PatentApplication Publication US 2011/0144373 (Swan et al., “Water SolubleDegradable Crosslinker”), the disclosure of which is incorporated hereinby reference.

In some aspects a non-ionic photoactivatable crosslinking agent can beused. In one embodiment, the non-ionic photoactivatable crosslinkingagent has the formula XR1R2R3R4, where X is a chemical backbone, and R1,R2, R3, and R4 are radicals that include a latent photoreactive group.Exemplary non-ionic crosslinking agents are described, for example, inU.S. Pat. Nos. 5,414,075 and 5,637,460 (Swan et al., “RestrainedMultifunctional Reagent for Surface Modification”). Chemically, thefirst and second photoreactive groups, and respective spacers, can bethe same or different.

In other embodiments, the non-ionic photoactivatable crosslinking agentcan be represented by the formula:

PG2-LE2-X-LE1-PG1

wherein PG1 and PG2 include, independently, one or more photoreactivegroups, for example, an aryl ketone photoreactive group, including, butnot limited to, aryl ketones such as acetophenone, benzophenone,anthraquinone, anthrone, anthrone-like heterocycles, their substitutedderivatives or a combination thereof; LE1 and LE2 are, independently,linking elements, including, for example, segments that include urea,carbamate, or a combination thereof; and X represents a core molecule,which can be either polymeric or non-polymeric, including, but notlimited to a hydrocarbon, including a hydrocarbon that is linear,branched, cyclic, or a combination thereof; aromatic, non-aromatic, or acombination thereof; monocyclic, polycyclic, carbocyclic, heterocyclic,or a combination thereof; benzene or a derivative thereof; or acombination thereof. Other non-ionic crosslinking agents are described,for example, in U.S. application Ser. No. 13/316,030 filed Dec. 9, 2011(Publ. No. US 2012/0149934) (Kurdyumov, “Photocrosslinker”), thedisclosure of which is incorporated herein by reference.

Further embodiments of non-ionic photoactivatable crosslinking agentscan include, for example, those described in US Pat. Publication2013/0143056 (Swan et al., “Photo-Vinyl Primers/Crosslinkers”), thedisclosure of which is incorporated herein by reference. Exemplarycrosslinking agents can include non-ionic photoactivatable crosslinkingagents having the general formula R1-X-R2, wherein R1 is a radicalcomprising a vinyl group, X is a radical comprising from about one toabout twenty carbon atoms, and R2 is a radical comprising aphotoreactive group.

A single photoactivatable crosslinking agent or any combination ofphotoactivatable crosslinking agents can be used in forming the coating.In some embodiments, at least one nonionic crosslinking agent such astetrakis(4-benzoylbenzyl ether) of pentaerythritol can be used with atleast one ionic crosslinking agent. For example, at least one non-ionicphotoactivatable crosslinking agent can be used with at least onecationic photoactivatable crosslinking agent such as anethylenebis(4-benzoylbenzyldimethylammonium) salt or at least oneanionic photoactivatable crosslinking agent such as4,5-bis(4-benzoyl-phenylmethyleneoxy)benzene-1,3-disulfonic acid orsalt. In another example, at least one nonionic crosslinking agent canbe used with at least one cationic crosslinking agent and at least oneanionic crosslinking agent. In yet another example, a least one cationiccrosslinking agent can be used with at least one anionic crosslinkingagent but without a non-ionic crosslinking agent.

An exemplary crosslinking agent is disodium4,5-bis[(4-benzoylbenzyl)oxy]-1,3-benzenedisulfonate (DBDS). Thisreagent can be prepared by combining4,5-Dihydroxylbenzyl-1,3-disulfonate (CHBDS) with4-bromomethylbenzophenone (BMBP) in THF and sodium hydroxide, thenrefluxing and cooling the mixture followed by purification andrecrystallization (also as described in U.S. Pat. No. 5,714,360,incorporated herein by reference).

Further crosslinking agents can include the crosslinking agentsdescribed in U.S. Publ. Pat. App. No. 2010/0274012 (to Guire et al.) andU.S. Pat. No. 7,772,393 (to Guire et al.) the content of all of which isherein incorporated by reference.

In some embodiments, crosslinking agents can include boron-containinglinking agents including, but not limited to, the boron-containinglinking agents disclosed in US Pat. Publication 2013/0302529 entitled“Boron-Containing Linking Agents” by Kurdyumov et al., the content ofwhich is herein incorporated by reference. By way of example, linkingagents can include borate, borazine, or boronate groups and coatings anddevices that incorporate such linking agents, along with relatedmethods. In an embodiment, the linking agent includes a compound havingthe structure (I):

wherein R1 is a radical comprising a photoreactive group; R2 is selectedfrom OH and a radical comprising a photoreactive group, an alkyl groupand an aryl group; and R3 is selected from OH and a radical comprising aphotoreactive group. In some embodiments the bonds B-R1, B-R2 and B-R3can be chosen independently to be interrupted by a heteroatom, such asO, N, S, or mixtures thereof.

Additional agents for use with embodiments herein can includestilbene-based reactive compounds including, but not limited to, thosedisclosed in U.S. Pat. No. 8,487,137, entitled “Stilbene-Based ReactiveCompounds, Polymeric Matrices Formed Therefrom, and ArticlesVisualizable by Fluorescence” by Kurdyumov et al., the content of whichis herein incorporated by reference.

Additional photoreactive agents, crosslinking agents, hydrophiliccoatings, and associated reagents are disclosed in U.S. Pat. No.8,513,320 (to Rooijmans et al.); U.S. Pat. No. 8,809,411 (to Rooijmans);and 2010/0198168 (to Rooijmans), the content of all of which is hereinincorporated by reference.

Natural polymers can also be used to form the hydrophilic base coat.Natural polymers include polysaccharides, for example, polydextrans,carboxymethylcellulose, and hydroxymethylcellulose; glycosaminoglycans,for example, hyaluronic acid; polypeptides, for example, solubleproteins such as collagen, albumin, and avidin; and combinations ofthese natural polymers. Combinations of natural and synthetic polymerscan also be used.

In some instances a tie layer can be used to form the hydrophilic baselayer. In yet other instances the tie layer can be added to thehydrophilic base layer. The tie layer can act to increase the adhesionof the hydrophilic base layer to the substrate. In other embodiments,the tie layer can act to increase adhesion of the hydrophobic activeagent to the hydrophilic base layer. Exemplary ties layers include, butare not limited to silane, butadiene, polyurethane and parylene. Silanetie layers are described in US Patent Publication 2012/0148852 (toJelle, et al.), the content of which is herein incorporated byreference.

In exemplary embodiments, the hydrophilic base layer can include tannicacid, polydopamine or other catechol containing materials.

The above detailed description is intended to be illustrative, and notrestrictive. The scope of the disclosure should, therefore, bedetermined with references to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1-5. (canceled)
 6. An insertion tool for facilitating the entry of aballoon catheter into the body, the tool comprising: first and secondelongate hollow bodies comprising proximal and distal ends, the firsthollow body having a proximal end with an outer diameter that isslidably movable within an inner diameter of a distal end of the secondelongate member, wherein the first hollow body includes an opening sizedto accommodate and allow the passage of a balloon portion of a ballooncatheter when the balloon portion is in a folded uninflated state. 7-10.(canceled)
 11. An insertion tool for facilitating the entry of a medicaldevice into the body, the tool comprising: a tubular member comprising awall and proximal and distal ends, and having a length between the endsdefining a first axis; first and second separation margins in the wallof the tubular member, the margins parallel to the first axis, oppositeone another on the tubular member, and between the proximal and distalends; wherein the separation margins comprise a continuous groove or aplurality of openings in the wall of the tubular member and define firstand second halves of the body member; wherein material of the tubularmember is configured to fracture along the length of the margins whenoutward forces are applied to each half the tubular member; at theproximal end of the tubular member, a first notch that is adjacent tothe proximal end of the first separation margin and a second notch thatis adjacent to the proximal end of the second separation margin; firstand second separation assist members connected to the proximal end ofthe tubular member and opposite one another on the tubular member andbetween the first and second notches, and a tapered distal end wherein athickness of the wall of the tubular member is reduced in a proximal todistal direct.
 12. An insertion tool for facilitating the entry of amedical device into the body, the tool comprising: a tubular membercomprising an wall having inner and outer surfaces and proximal anddistal ends and having a length between the ends defining a first axis;wherein the inner surface, the outer surface, or both, of the wallcomprises a plurality of ridges running parallel to the first axis andabout the circumference of the inner wall, wherein the ridges defineareas of the wall having a first thickness, and between the ridges areasof the wall having a second thickness wherein the first thickness isgreater than the second thickness; wherein material of the tubularmember is configured to fracture along the length of the wall betweenthe ridges when outward forces are applied to each half the tubularmember; at the proximal end of the tubular member, a first notch that isadjacent to the proximal end of a first area of the of the tubularmember that is between a first set of two ridges, and a second notchthat is adjacent to the proximal end of a second area of the of thetubular member that is between a second set of two ridges; and first andsecond separation assist members connected to the proximal end of thetubular member and opposite one another on the tubular member andbetween the first and second notches.
 13. A method for delivering amedical device into a patient's body, comprising steps of (a) providingan insertion tool of claim 11 or 12 loaded with an implantable orinsertable medical device, and (b) moving, directly or indirectly, theinsertable or implantable medical device from the insertion tool intothe patient's body.
 14. The method of claim 13 wherein the insertablemedical device comprises a balloon catheter. 15-20. (canceled)
 21. Theinsertion tool of claim 11 wherein the first and second notches taperfrom wider to narrower in a proximal to distal direction.
 22. Theinsertion tool of claim 11 wherein the first and second separationassist members have outer edges and widths that widen toward the outeredges.
 23. The insertion tool of claim 11 wherein the first and secondseparation assist members are in the form of tabs.
 24. The insertiontool of claim 11 wherein the first and second separation assist membersare bendable outwards and inwards.
 25. The insertion tool of claim 11wherein the first and second separation assist members are proximalextensions of the tubular member, or are attached as independent membersto the proximal end of the tubular member using an adhesive.
 26. Theinsertion tool of claim 11 wherein the distal end of the tubular memberis tapered.
 27. The insertion tool of claim 26 wherein at the tapereddistal end the thickness of the wall of the tubular member is reduced ina proximal to distal direction.
 28. A system for the introduction of aballoon catheter into an artery comprising the insertion tool of claim11 and a hemostatic valve.
 29. The system of claim 28 wherein thehemostatic valve comprises proximal and distal openings, the distalopening adapted to enter an artery, and wherein the distal end of theinsertion tool is configured to be moved through the proximal and distalopenings of the hemostatic valve.
 30. The system of claim 28 whereinsystem further comprises a balloon catheter comprising a balloon end,wherein the insertion tool is configured to accommodate the balloon endof the balloon catheter.
 31. The method of claim 14 wherein the ballooncatheter comprises a balloon end and the balloon end is loaded in withinthe tubular member of the insertion tool.
 32. The method of claim 31wherein the insertion tool with loaded balloon end of the ballooncatheter is moved through a hemostatic valve to place a distal portionof the insertion tool within an artery of the patient's body.
 33. Themethod of claim 32 further comprising a step of withdrawing theinsertion tool from the artery and the hemostatic valve whilemaintaining the balloon end in the artery.
 34. The method of claim 33further comprising a step of applying outward force to the first andsecond separation assist members causing the tubular member to fracturealong the length of the margins, and removing the fractured insertiontool.